Hyperbaric Oxygen Therapy in Chronic Traumatic Brain Injury or Post-Traumatic Stress Disorder (NBIRR-1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01105962|
Recruitment Status : Terminated (new regulatory requirements will require funding for restart as a new study)
First Posted : April 19, 2010
Last Update Posted : September 20, 2016
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This is an observational research study whose purposes are to see:
- if 40 Hyperbaric Oxygen Therapy sessions at 1.5 atmospheres (HBOT 1.5) or more (60, or 80 HBOT's) help, worsen, or have no effect on subjects with chronic TBI/PCS (Traumatic Brain Injury/Post-Concussion Syndrome) and/or PTSD (Post-Traumatic Stress Disorder).
- if improvements or worsening of symptoms can be recorded with computerized and written tests for memory and thinking, and with questionnaires about the subject's quality of life and health.
- determine the long-term outcome of the treatment.
- confirm, in large numbers of study participants at multiple sites nationwide, the strong positive results obtained in pilot studies
|Condition or disease|
|Traumatic Brain Injury Post-traumatic Stress Disorder|
|Study Type :||Observational|
|Actual Enrollment :||133 participants|
|Official Title:||Multicenter Observational Study of Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post-Concussion Syndrome (PCS) and/or TBI/Post-Traumatic Stress Disorder (PTSD)|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
- Cognitive Function [ Time Frame: 2-6mo then every 6 months for 2yrs ]
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
One thousand subjects will be recruited. Subjects will be 18-65 years old and have been diagnosed with mild or moderate (but not severe) TBI or TBI/PTSD or PTSD by either the military (any etiology) or civilian neurologists or neuropsychologists. This diagnosis will especially include war veterans who have had a significant decrease in their neuropsychological test scores.
There will be no gender restriction. However, it is anticipated that the cohort will consist mostly of males, due to the nature of the injury. There will be no race or ethnicity restriction.
All subjects will be legally capable of consenting. No subjects who need 3rd party consent will be enrolled in the NBIRR study.
Military - Unless specifically approved by a military site IRB, active duty participants will have to voluntarily contact NBIRR participating sites or respond to a recruitment outreach outside of the command.
- Any 18-65 year-old patient with mild-moderate TBI or PTSD. (If a military injury, subject may be active duty or a veteran. If active duty, participants will have to voluntarily contact NBIRR.)
- Have demonstrated a >20% decrement (compared to pre-deployment baseline) in ANAM composite score or specific sub-score with regard to "simple reaction time" and/or "procedural reaction time".
- Have a diagnosis of TBI, chronic TBI/PCS or TBI/PCS/PTSD or PTSD made by a military (military etiology of blast injury) or civilian specialist.
- Negative pregnancy test in females.
- Less than 90% on the Percent Back to Normal Rating Scale. (If patient is considered 100% normal before TBI, patient should be less than 90% normal for entry into the study).
- Pulmonary disease that precludes HBOT (e.g., asthma unresponsive to medication, bullous emphysema).
- Unstable medical conditions that are contraindicated in HBOT (e.g. severe congestive heart failure or heart failure requiring hospital emergency evaluation or admission in the previous year).
- Severe confinement anxiety (claustrophobia; e.g., patients who require anesthesia conscious sedation for MRI or who cannot go in elevators).
- Other pre-TBI neurological diagnoses.(seizure disorders, multiple sclerosis, Parkinson's, Lyme, etc.)
- Participation in another experimental trial with active intervention.
- High probability of inability to complete the experimental protocol (e.g. terminal condition).
- Past or current history of mental retardation unless diagnosed post TBI (baseline IQ ≤ 70).
- Pre- or post-TBI history of systemic illness with impact on central nervous system. (Principal Investigator in consultation with study sponsor Medical Officer will make the ultimate decision).
- Any pre-existing chronic infection not related to battlefield injuries or government service.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01105962
|United States, California|
|San Francisco Institute for Hyperbaric Medicine|
|San Francisco, California, United States, 94107|
|United States, Colorado|
|Rocky Mountain Hyperbaric Institute|
|Boulder, Colorado, United States, 80301|
|United States, Florida|
|Hyperbaric Services of the Palm Beaches|
|Del Ray Beach, Florida, United States, 33484|
|Hyperbaric Medicine Inc. of Florida|
|Ft. Walton Beach, Florida, United States, 32547|
|United States, Idaho|
|Idaho Wound Care & Hyperbaric Medicine|
|Pocatello, Idaho, United States, 83201|
|United States, Minnesota|
|Plymouth, Minnesota, United States, 55447|
|United States, Nevada|
|Hyperbaric Institute of Nevada and Clinical Neurology Specialists|
|Henderson, Nevada, United States, 89012|
|United States, Ohio|
|Alliance Community Hospital Wound Care and Hyperbaric Department|
|Alliance, Ohio, United States, 44601|
|United States, Virginia|
|HBOT NOVA - Hyperbaric Oxygen Therapy of Northern Virginia|
|Reston, Virginia, United States, 20190|
|United States, Wisconsin|
|Fox Valley Wellness Center|
|Fond du Lac, Wisconsin, United States, 54935|
|Study Director:||B Robert Mozayeni, MD||International Hyperbaric Medical Foundation|
|Responsible Party:||International Hyperbaric Medical Foundation|
|Other Study ID Numbers:||
|First Posted:||April 19, 2010 Key Record Dates|
|Last Update Posted:||September 20, 2016|
|Last Verified:||September 2016|
Brain Injuries, Traumatic
Wounds and Injuries
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Trauma and Stressor Related Disorders